MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 6 ASPIRATION CATHETER; DXE

Catalog Number CAT6

Device Problems Retraction Problem (1536); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the cat6 was stretched and fractured approximately 124.0 cm from the hub.The distal segment of the cat6 was ovalized and kinked throughout its length.The proximal segment of the cat6 was kinked in multiple locations throughout its length.Conclusions: evaluation of the returned device revealed the cat6 was stretched and fractured in the distal shaft.It is possible for the cat6 to become pinned against patient anatomy or other devices used in the procedure.If the cat6 becomes pinned or otherwise restrained, and the guidewire or cat6 is forcefully retracted against resistance, stretching and fracture damage may occur.Further evaluation revealed the distal segment of the cat6 was kinked and ovalized throughout its length.This damage likely occurred due to forceful manipulation of the cat6 during navigation of patient anatomy.The kinks throughout the proximal segment were likely incidental and may have occurred during packaging for return to penumbra.The guidewire mentioned in the complaint was not returned for evaluation.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure in the femoral artery using an indigo system aspiration catheter 6 (cat6).During the procedure, while attempting to retract a guidewire from a cat6, the cat6 grabbed the guidewire and it became stuck; therefore, the cat6 and guidewire were removed.The procedure was completed using infusion catheters.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT 6 ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7355782
• MDR Text Key: 103177087
• Report Number: 3005168196-2018-00614
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/14/2020
• Device Catalogue Number: CAT6
• Device Lot Number: F79522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR